Systematic review and meta-analysis of the efficacy of biologic and targeted synthetic therapies in sarcoidosis.

The efficacy of other anti-TNF agents, non-TNF biologics and targeted synthetic therapies remains unclear.

其他抗TNF药物、非TNF生物制剂和靶向合成治疗的疗效尚不明确。

This study aims to evaluate the role of these therapies in the management of multisystem sarcoidosis.

本研究旨在评估这些疗法在多系统性结节病管理中的作用。

Methods

We conducted a systematic literature search to identify trials of biological and targeted synthetic therapies in sarcoidosis.

我们进行了一项系统文献检索，以确定在结节病中进行的生物制剂和靶向合成治疗的试验。

Meta-analyses examined %-predicted forced vital capacity (FVC), as mean change from baseline.

荟萃分析考察了预测值的用力肺活量（FVC），作为从基线开始的平均变化。

Heterogeneity was measured using the I2 statistic.

使用I2统计量来衡量异质性。

Vote counting based on the direction of effect, as recommended by the Cochrane network, was used to synthesise study estimates.

根据Cochrane网络推荐的效应方向进行投票计数，用于综合研究估计值。

Results

The search identified 6777 records.

搜索识别了6777条记录。

Sixteen studies met the inclusion criteria.

共有16项研究符合纳入标准。

These included 8 randomised control trials (RCTs) and 8 single-arm trials.

其中包括8项随机对照试验（RCTs）和8项单臂试验。

Fourteen studies evaluated biologic therapies: infliximab (n=5), adalimumab (n=2), etanercept (n=2), golimumab (n=1), rituximab (n=1), anakinra (n=1), sarilumab (n=1), ustekinumab (n=1) and efzofitimod (n=1).

十四项研究评估了生物治疗药物：英夫利昔单抗（n=5），阿达木单抗（n=2），依那西普（n=2），戈利木单抗（n=1），利妥昔单抗（n=1），阿那金拉（n=1），萨利单抗（n=1），乌司他木单抗（n=1）和efzofitimod（n=1）。

Two trials assessed the targeted synthetic therapy tofacitinib.

两项试验评估了靶向合成治疗药物托法替尼。

Risk of bias was high in five of eight RCTs.

八项随机对照试验中，有五项的偏倚风险较高。

Meta-analysisof %-predicted FVC showed modest improvement with treatment (mean change: 4.79% (95% CI 1.22 to 8.35), driven by anti-TNF trials 5.70% (95% CI 1.61 to 9.78).

%-预测的用力肺活量(FVC)的荟萃分析显示，治疗后有适度改善（平均变化：4.79%（95%置信区间1.22至8.35）），这一结果主要由抗TNF试验推动，其平均变化为5.70%（95%置信区间1.61至9.78）。

Heterogeneity was substantial (I²=76.3%).

异质性很大（I²=76.3%）。

In data synthesis using vote counting, infliximab, adalimumab, efzofitimod and tofacitinib demonstrated a positive direction of effect across all estimates, though improvements in several outcomes did not reach thresholds for minimal clinically important differences.

在使用投票计数法进行数据综合时，英夫利昔单抗、阿达木单抗、efzofitimod和托法替尼在所有估计中显示出积极的效果方向，尽管在几个结果上的改善并未达到最小临床重要差异的阈值。

Conclusions

Meta-analysissupports infliximab use in pulmonary sarcoidosis, although improvements in lung function are modest.

荟萃分析支持在肺部结节病中使用英夫利昔单抗，尽管肺功能的改善是适度的。

There is limited but promising evidence for the use of adalimumab and tofacitinib in cutaneous disease and efzofitimob in pulmonary disease.

在皮肤病和肺部疾病中使用阿达木单抗、托法替尼和efzofitimob的证据有限但有希望。

Study interpretation is limited by small sample sizes and heterogeneity in study design and population.PROSPERO registration numberCRD42024599560.

由于样本量小和研究设计及人群的异质性，研究解释受到限制。